BACKGROUND Reduction in absolute lymphocyte count (ALC) is expected with fingolimod treatment. OBJECTIVE To evaluate the effect of fingolimod 0.5 mg versus intramuscular interferon β-1a (30 μg) on ALC and its relationship with infections in paediatric-onset multiple sclerosis (POMS) up to 4 years. METHODS We assessed ALC at baseline, monthly till 3 months, and every 3 months (core phase) and with variable periodicity (extension phase) of Phase 3 PARADIGMS study (N = 215). Incidence rates (IRs) of infection-related adverse events (infAEs)/100 patient-years were analysed by on-study nadir ALC. RESULTS With fingolimod, ALC rapidly reduced to 29.9%-34.4% of baseline values within 2 weeks and remained stable thereafter; no relevant changes observed with interferon. IRs of infAEs were 67.6 with fingolimod and 61.8 with interferon; IR ratios with respect to interferon, overall: 1.09, by nadir ALC 0.2-0.4 × 109/L: 1.13 and >0.4 × 109/L: 0.91. Three patients had a single episode of ALC <0.2 × 109/L (core phase). No opportunistic infections were observed and infection risk did not increase during the extension phase. CONCLUSION In paediatric patients, the overall incidence of infections was comparable between fingolimod and interferon. No association was observed between nadir ALC and infections in POMS, although sample size may have been too small to rule an association.

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多发性硬化症儿科患者淋巴细胞计数的时间分布及其与芬戈莫德治疗感染的关系：来自 PARADIGMS 研究的结果

背景 芬戈莫德治疗预计会降低绝对淋巴细胞计数 (ALC)。目的 评估芬戈莫德 0.5 mg 与肌内注射干扰素 β-1a (30 μg) 对 ALC 的影响及其与小儿多发性硬化症 (POMS) 感染长达 4 年的关系。方法 我们评估了基线、每月至 3 个月和每 3 个月（核心阶段）和第 3 阶段 PARADIGMS 研究（N = 215）的可变周期（扩展阶段）的 ALC。感染相关不良事件 (infAE) 的发生率 (IR)/100 患者年通过研究中的最低点 ALC 进行分析。结果 使用芬戈莫德后，ALC 在 2 周内迅速降低至基线值的 29.9%-34.4%，此后保持稳定；没有观察到干扰素的相关变化。芬戈莫德的 infAE 的 IR 为 67.6，干扰素为 61.8；关于干扰素的 IR 比值，总体：1.09，最低点 ALC 0.2-0.4 × 109/L：1.13 和 >0.4 × 109/L：0.91。三名患者有一次 ALC <0.2 × 109/L（核心期）。在扩展阶段没有观察到机会性感染，感染风险也没有增加。结论 在儿科患者中，芬戈莫德和干扰素的总体感染发生率相当。未观察到最低点 ALC 与 POMS 感染之间存在关联，尽管样本量可能太小而无法确定关联。芬戈莫德和干扰素之间的总体感染发生率相当。未观察到最低点 ALC 与 POMS 感染之间存在关联，尽管样本量可能太小而无法确定关联。芬戈莫德和干扰素之间的总体感染发生率相当。未观察到最低点 ALC 与 POMS 感染之间存在关联，尽管样本量可能太小而无法确定关联。